| Primary | Change From Baseline to Week 12 in 1h Post-dose FEV1 | 1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued). | All patients randomized who:
- received at least one dose of study medication;
- the patient contributed data for at least one efficacy endpoint.
Patients accounted for according to the treatment to which they were randomized. | Posted | | Least Squares Mean | 95% Confidence Interval | Liters | | Week 0 (baseline), Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID | | OG002 | Budesonide pMDI 80 ug | Budesonide pMDI 80 ug x 2 BID |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.28(0.22 to 0.34)
- OG0010.24(0.18 to 0.31)
- OG0020.17(0.10 to 0.23)
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor. | 0.006 | | | | | | | | | | | | | | Superiority or Other | | | | | Mixed Models Analysis | |
|
| Secondary | Change From Baseline to Week 12 in 1h Post-dose PEF | 1h post-dose PEF is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued). | All patients randomized who:
- received at least one dose of study medication;
- the patient contributed data for at least one efficacy endpoint.
Patients accounted for according to the treatment to which they were randomized. | Posted | | Least Squares Mean | 95% Confidence Interval | Liters per minute | | Week 0 (baseline), Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID | | OG002 | Budesonide pMDI 80 ug | Budesonide pMDI 80 ug x 2 BID |
| |
| Secondary | Change From Baseline to Week 12 in 1h Post-dose FEF25-75 | 1h post-dose FEF25-75 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued). | All patients randomized who:
- received at least one dose of study medication;
- the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Posted | | Least Squares Mean | 95% Confidence Interval | Liters per second | | Week 0 (baseline), Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID | | OG002 | Budesonide pMDI 80 ug | Budesonide pMDI 80 ug x 2 BID |
| |
| Secondary | Change From Baseline to Week 12 in 1h Post-dose FVC | 1h post-dose FVC is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued). | All patients randomized who:
- received at least one dose of study medication;
- the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Posted | | Least Squares Mean | 95% Confidence Interval | Liters | | Week 0 (baseline), Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID | | OG002 | Budesonide pMDI 80 ug | Budesonide pMDI 80 ug x 2 BID |
| |
| Secondary | Change From Baseline to Week 12 in Pre-dose FEV1 | Pre-dose FEV1 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued). | All patients randomized who:
- received at least one dose of study medication;
- the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Posted | | Least Squares Mean | 95% Confidence Interval | Liters | | Week 0 (baseline), Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID | | OG002 | Budesonide pMDI 80 ug | Budesonide pMDI 80 ug x 2 BID |
| |
| Secondary | Change From Baseline to Week 12 in Pre-dose PEF | Pre-dose PEF is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued). | All patients randomized who:
- received at least one dose of study medication;
- the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Posted | | Least Squares Mean | 95% Confidence Interval | Liters per minute | | Week 0 (baseline), Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID | | OG002 | Budesonide pMDI 80 ug | Budesonide pMDI 80 ug x 2 BID |
| |
| Secondary | Change From Baseline to Week 12 in Pre-dose FEF25-75 | Pre-dose FEF25-75 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued). | All patients randomized who:
- received at least one dose of study medication;
- the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Posted | | Least Squares Mean | 95% Confidence Interval | Liters per minute | | Week 0 (baseline), Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID | | OG002 | Budesonide pMDI 80 ug | Budesonide pMDI 80 ug x 2 BID |
| |
| Secondary | Change From Baseline to Week 12 in Pre-dose FVC | Pre-dose FVC is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued). | All patients randomized who:
- received at least one dose of study medication;
- the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Posted | | Least Squares Mean | 95% Confidence Interval | Liters | | Week 0 (baseline), Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID | | OG002 | Budesonide pMDI 80 ug | Budesonide pMDI 80 ug x 2 BID |
| |
| Secondary | Change From Baseline to Week 12 in 15 Min Post-dose FEV1 | 15 min Post-dose FEV1 is defined as the 15 min post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued). | All patients randomized who:
- received at least one dose of study medication;
- the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Posted | | Least Squares Mean | 95% Confidence Interval | Liters | | Week 0 (baseline), Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID | | OG002 | Budesonide pMDI 80 ug | Budesonide pMDI 80 ug x 2 BID |
| |
| Secondary | Change From Baseline to End of Study Average in Total Asthma Symptoms | End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued). Patient to record his/her asthma symptom score twice daily. The following rating scales are to be used: 0 = None; no symptoms of asthma
- = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated
- = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep
- = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep
Total asthma symptom score is derived as the sum of the daytime score plus the score from the previous nighttime, ie possible range (0 to 6). | All patients randomized who:
- received at least one dose of study medication;
- the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Posted | | Mean | Standard Deviation | units on a scale | | Week 0 (baseline), Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID |
|
| Secondary | Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms | End of study average is defined as the percentage of nighttime awakenings due to asthma symptoms from 6 days before up to and additionally including the morning of withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued). | All patients randomized who:
- received at least one dose of study medication;
- the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Posted | | Mean | Standard Deviation | Percentage of nighttime awakenings | | Week 0 (baseline), Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID | | OG002 | Budesonide pMDI 80 ug | Budesonide pMDI 80 ug x 2 BID |
| |
| Secondary | Change From Baseline to End of Study Average in Total Daily Reliever Medication | End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued). | All patients randomized who:
- received at least one dose of study medication;
- the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Posted | | Mean | Standard Deviation | Number of reliever medication use | | Week 0 (baseline), Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID | | OG002 | Budesonide pMDI 80 ug | Budesonide pMDI 80 ug x 2 BID |
| |
| Secondary | Change From Baseline to Study Period Average in Overall PAQLQ Score | Study period average is defined as the average of the post-baseline values during the study taken after first dose of investigational product up to and including withdrawal from study or Week 12, minus the baseline assessment at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued). The PAQLQ(S) is a 23-item patient-reported questionnaire, each one reported on a 7-point scale (e.g. 1 = extremely bothered/all of the time; 7 = not bothered/none of the time). The PAQLQ(S) generates an overall score, as well as 3 domain scores: activity limitations (5 items), symptoms (10 items) and emotional function (8 items). The overall score will be calculated as the mean of the responses to each of the 23 questions (ie the range of 1-7, where higher scores indicate better quality of life). If any of the domain scores are missing, no total score will be calculated. | All patients randomized who:
- received at least one dose of study medication;
- the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Posted | | Least Squares Mean | 95% Confidence Interval | unit on a scale | | Week 0 (baseline), week 4, week 8, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID |
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| Secondary | Number of Patients With an Asthma Exacerbation During Study | Number of patients that experienced an asthma exacerbation that required either emergency room treatment, hospitalization, systemic steroids, or an increase in, or additional asthma maintenance medication, during the study. | All patients randomized who:
- received at least one dose of study medication;
- data collected after randomisation. Patients accounted for according to the treatment they actually received.
| Posted | | Number | | Partcicipants | | Week 0 (baseline) up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/4.5 ug x 2 BID | | OG001 | Symbicort pMDI 80/2.25 ug | Symbicort pMDI 80/2.25 ug x 2 BID | | OG002 | Budesonide pMDI 80 ug | Budesonide pMDI 80 ug x 2 BID |
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